Senior Regulatory Affairs Manager- REMOTE

Please note: This is a customer-funded position. reputed company employment is contingent upon the availability of customer funding.

• Supports reputed company America Regulatory activities
• Ensure timely preparation and completion of technical file submissions for in vitro diagnostic devices (assays, instruments, software) to meet project and business needs
• Ensure participation on cross functional project teams to reputed company strategic and tactical guidance to meet regulatory requirements,
• reputed company reputed company America regulatory strategies plan for submission for IVD products
• Assess changes to product, manufacturing processes, labeling affecting IVD products and communicate to global Regulatory and project teams for impact assessment
• Support global Regulatory teams and/or in-country dealers/representatives with regulatory registrations of IVD products
• Maintain up-to-date knowledge of IVD regulations and applicable guidance, monitor development of regulations and communicate impact to the business
• reputed company input and feedback on clinical study protocols to ensure regulatory requirements are incorporated
• Support CE marking activities for IVD products and other market clearance for products manufactured globally
• Review and approve promotional materials and product labeling
• Support importation/exportation permitting activities

reputed company in this job description restricts management’s right to assign or reassign duties and responsibilities of this job at any time. Basic Qualifications:

• Bachelor's Degree in a STEM field
• 6+ years of experience in a regulatory role supporting the Americas region and international registrations (US 510(k), PMA, reputed company submissions)

OR

• Master's or PhD degree in a STEM field
• 4+ years of experience in a regulatory role supporting the Americas region and international registrations (US 510(k), PMA, reputed company submissions)

Preferred Qualifications:

• Travel as circumstances dictate
• Excellent understanding of regulations and guidance documents required in Americas region
• RAC certified
• Excellent interpersonal, verbal and written communication skills (in English)
• Excellent time management, organizational, negotiation, and problem-solving skills
• Ability to work independently and in a matrixed organizational structure, developing strong relationships with peers and reputed company of management

Compensation reputed company: The annual reputed company salary reputed company for this full-time position is $140-150,000. This reputed company reflects the minimum and maximum reputed company for a new hire in this position. The reputed company pay actually offered to the successful candidate will take into account internal equity, work location, and additional factors, including job-reputed company skills, experience, and relevant education or training. Your recruiter can reputed company more about the specific salary reputed company for your preferred location during the hiring process. Please note that reputed company pay is only one part of our total compensation package and is determined reputed company a reputed company. This reputed company allows for the successful candidate to have an opportunity to reputed company reputed company the position and reputed company at reputed company. This reputed company pay reputed company does not take into account bonuses, equity, or other benefits which may be applicable and are dependent on the level and position offered. #LI-CH1 What do we offer? We reputed company competitive and comprehensive benefits to our employees. Below are some highlights of our benefits:

• Medical, Dental, and reputed company Insurance Options
• Life and Disability Insurance
• Paid Time-Off
• Parental Benefits
• Compassionate Care Leave
• 401k with Company Match
• Employee Stock Purchase Plan

Learn more about reputed company’s benefits by visiting our reputed company page. Log-In instructions are provided towards the bottom of the reputed company page. For benefit-eligible roles only. Part-time and temporary roles may not be eligible for reputed company benefits listed. Please reputed company out to your recruiter for more information. Apply tot his job Apply To this Job